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Shortened hormone therapy did not reduce survival of patients with high-risk prostate cancer
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Patients with high-risk prostate cancer who received 18 months of hormone therapy lived as long as patients who underwent 36 months of therapy, according to results of a phase 3 study presented at the Genitourinary Cancers Symposium.
Standard treatment for men diagnosed with high-risk prostate cancer consists of radiotherapy plus hormone therapy, also called androgen blockade therapy, for 24 to 36 months. Many side effects associated with androgen blockade therapy worsen over the course of treatment.
The optimal duration of hormone therapy has yet to be defined, according to background information provided by researchers.
“Shorter-term hormone therapy could have a big impact on the lives of men with prostate cancer, reducing the quantity and intensity of its unpleasant side effects, as well as treatment costs,” Abdenour Nabid, MD, FRCPC, associate professor at Centre Hospitalier Universitaire de Sherbrooke in Canada, said in a press release.
Nabid and colleagues evaluated whether androgen blockade duration could be safely reduced from 36 to 18 months among patients with high-risk, node-negative prostate cancer.
The researchers randomly assigned patients to either 18 months (n=320) or 36 months (n=310) of androgen blockade therapy before, during and after pelvic and prostate radiotherapy. Radiotherapy started 4 months after patients began androgen blockade therapy.
After median follow-up was 77 months, results showed comparable OS between the two arms.
Researchers reported 77.1% of patients assigned to 36-month therapy were alive at follow-up, compared with 76.2% of those assigned to 18-month therapy (P=.802).
The investigators also found comparable 5-year OS (92.1% vs. 86.8%) and 10-year OS (63.6% vs. 63.2%) between the two groups.
“Eighteen months of androgen blockade could represent a threshold effect with no further benefit for patients,” Nabid said during a press conference held prior to the symposium.
The researchers reported 10-year disease-specific survival of 87.2% for both groups.
“For the benefit of the patients, we hope these results will convince doctors that they can stop hormone therapy after one-and-a-half years instead of 2 to 3,” Nabid said.
For more information:
Nabid A. Abstract #3. Presented at: Genitourinary Cancers Symposium; Feb. 14-16, 2013; Orlando.
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Bruce J. Roth, MD
When you look at the list of side effects, you may ask why anyone would proscribe androgen blockade therapy, but we have randomized trials showing that hormone therapy plus radiotherapy actually improves survival in this patient population. What is the long-term impact of this? The longer period you are on hormone therapy, the less chance testosterone recovers. It is possible if you gave 3 years of hormone therapy to a patient, you may be inducing a lifetime’s worth of hormonal deprivation along with its long-term side effects. This is an important study because it shows halving hormone therapy does not have a negative impact on outcome. Can we get by with less than 18 months? We know in previous randomized trials that 6 months is inferior. At least this is a first attempt at the reduction of the amount of hormone therapy to which we expose patients… It may well change the standard of care for patients with this stage of disease.
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